Saturday, April 28, 2012

In our rush to establish a national electronic medical record (EMR) system as part of the American Recovery and Reinvestment Act of 2009, powerful silos of independent EMR systems have sprung up nationwide. While most systems are being developed responsibly, like the Wild, Wild West, many have been developed without an objective eye toward quality and the potential harm they may be causing our patients.

As most readers of this blog are aware, since 2005 the medical device industry in which I work has had widely publicized instances of patient deaths splashed all over the New York Times and other mainstream media outlets from defibrillator malfunctions that resulted in a just a few patient deaths. The backlash in response to these deaths was significant: device registries were developed, software improvements to devices created, and billions of dollars in legal fees and damages paid to patients and their families on the path to improvement. In addition, we also learned about the limits of corporate responsibility for these deaths thanks to legal precedent established by the Reigel vs. Medtronic case.

Should Electronic Medical Records Be Considered Medical Devices?

This week I received a medical record from a large academic medical center somewhere in the United States (the details are unimportant) that has one of these new pioneering EMR systems manufactured by $13 billion-dollar company, Cerner Corporation. Now before I go on a rant about Cerner's EMR system, I should preface my remarks to say that I have never personally used Cerner's system. But I am a doctor who received a note composed on Cerner's system and what I saw was one of the better examples of how EMR's are contributing to misinformation and confusion when health care is delivered.

I received a copy of an internal medicine consult that was performed on a patient at this outside hospital. I have extracted the "medications" portion of the internist's note exactly as it was displayed in the note below (although the list extended over more than one page, so I joined the list together as one figure). Needless to say, I was terrified at what the system had listed as the patient's medications:

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Med List (Page 1) - Click to enlarge

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Med List (Page 2) - Click to enlarge

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In this example, we see multitudes of medications listed more than once. We see drugs of similar classes (antihistamines, beta blockers) on the same list. We see warfarin, one of our most dangerous drugs dispensed, without a dose included. We see what seems to be outpatient meds listed with inpatient meds, I'm not sure. Honestly, we really have no idea what medications are actually being taken from this list. And yet this list of medications is listed by the EMR as the patient's "Active Medications."

What the heck have we created?

Certainly, any capable physician who cares for patients would describe this medication list as worthless. So why is it in there? (Don't get me wrong, the fact that any doctor would allow such crap to be displayed in his or her medical note by using an EMR shortcut to enter them uncorrected is beyond me. Certainly, we as doctors must accept a big portion of the responsibility for this).

But when EMR developers and their hospital administration customers purchase software capable of spewing forth completely useless AND potentially lethal information about our patients that is then transmitted far and wide, (not to mention to local direct caregivers) doctors have an obligation to speak up.

These kinds of documentation problems are the EMR's Achilles' heel. But beyond this, EMR software updates are routinely deployed without real-world real-life testing. Ever. And yet, like patients with a defibrillator who die outside the hospital before a root cause of a defibrillator defect can be discovered, I acknowledge that it is incredibly difficult to prove that the death of an individual was caused by an EMR software problem.

And yet, we must.

So how will we measure problems with EMRs? It seems industry representatives would rather not address these concerns. We should ask ourselves, is anyone thinking about this?

Right now, the prevailing belief is that the electronic medical record might be one of the most important medical devices doctors have at our disposal to care for patients. I tend to agree. But it's potential to do harm is also enormous if it is not used responsibly and accurately. After all, as the above example shows, the potential to introduce unintended yet potentially lethal errors into patient care is huge. More importantly, since nearly every person in the United States will soon have their medical data housed within these systems, the number of people that could be adversely affected by these systems is much larger than what we've seen with our recent defibrillator malfunctions.

Perhaps, like the ICD registry, we should try to to develop an EMR registry of adverse patient outcomes caused by these software systems. That way, every independent EMR company can learn from the other's mistakes. Because, guess what ...

... like other man-made medical devices, EMR's are not perfect either.

Friday, April 27, 2012

In 2005, a flurry of medical device recalls shook the implantable cardiac defibrillator market. The first of these recalls occurred after the former Guidant Corporation (just purchased by Boston Scientific) was forced to admit that a header malfunction of one of their Prism II ICD's had short-circuited and failed to deliver appropriate resusciating shocks to several patients. The company had decided not disclosed the known defect immediately to physicians since the frequency of the events were rare. It was only after two physicians reported their findings to the mainstream media, that a recall of the device was announced the following day. Guidant stock tanked. A flurry of negative press and lawsuits resulted and the ICD market was forever changed.

Shortly thereafter Guidant's other competitors had recalls of their defibrillator pulse generators. First, Medtronic had a defibrillator battery with a shorting issue. To avoid the fallout that Guidant had experienced, they initiated a "recall" and offered to pay for device replacement. Hundreds of devices were replaced nationwide as a result. Unfortunately, another problem came to light as a result of that action: infection. Only after some time was it recognized that the infection rate of device replacement was higher than the device failure the replacements were supposed to fix.

Time offers unique insights to device problems, we learned.

Even St. Jude Medical, who escaped the early firestorm of recalls, had their own issue with cosmic radiation's effects on some of the components of their devices. Another physician advisory letter was issued. Fortunately, the lessons from the other generator recalls helped doctors to be slower to react reflexively. A more cautious wait and watch approach ensued.

The development of a robust registry of implanted device utilization took on new urgency. Devices capable of self-checks that automatically transmit alerts to a central database without patient intervention were developed (see here, here, and here). We felt we were on top of our game.

But then the problems with pulse generators evolved to defibrillator leads. In October, 2007, Medtronic's down-sized but highly popular 7-French Sprint Fidelis defibrillator lead was beginning to show a higher-than-expected failure rate. Several deaths occurred as a result. At first when Medtronic attempted to determine a "root cause" for the problem, they identified several clusters of failure and suggested to physicians that the problems might be due to physician implant technique. Later when it became obvious that even there most trusted implanters were having problems with the lead, Medtronic had a "mea culpa" moment and issued a sweeping lead "advisory." (There was concern that the word "recall" might spur doctors to extracting these leads in all cases). And while many of those leads are still in place today, it is clear the Sprint Fidelis still shows problems with its reliability over time. To facilitate , careful survellance of the leads using software enhancements to existing devices, the problem appears to be managable, though remains challenging.

More recently in 2010, St. Jude Medical recalled earlier versions of their downsized 7Fr Riata and Riata ST defibrilaltor leads because of a different failure mechanism: so-called "inside-out" insulation problems. Deaths were reported with this lead also, but St. Jude took the unusual tactic of seeking a withdrawl of the information from a peer reviewed journal, arguing that the analysis of their lead's performance was improper when it's characteristics were compared to their competitor's defibrillator lead that remains on the market. Given the history of the market recalls before, implanting doctors (including this one) were surprised to see such an action. Where things will fall out on this issue continues to evolve.

What is clear from all of this, is that these devices, no matter how wonderful they may seem, all can have problems. In fact, electrophysiologists are increasingly aware of system components that might fail and lead to problems with these devices, irrespective of manufacturer. As much as we'd like to think these amazing devices are fool-proof, we are constantly reminded they are not.

But an interesting thing happened earlier this week; something that was a welcome development in this continuing saga of device recalls and advisories.

Yesterday, the press got hold of Boston Scientific's latest "product performance update" notification that involved a transformer component of one of their newer defibrillator product lines that, by Boston Scientific's own admission, had resulted in one patient death. Predicably, the stock market price of Boston Scientific plummeted with the news. The major news organizations spread the news far and wide. But then the stock price rebounded to within 8 cents of the stock's price before the news.

Why?

Unlike the original Guidant mess in 2005, Boston Scientific took the step of quietly notifying their physician base over a week before the news hit the wire by way of a personalized request to review their latest "product performance report.". The magnitude of the problem was fairly well quanitated, occurring in an estimated "1 in 8900 devices." Doctors had time to digest the information, and while still concerning, it's implications to patients understandable when compared to the problems with other advisories. While still early in this latest advisory, doctors are increasingly realizing that these problems with the many human-made components of these devices are not infallible.

So we're seeing a glimpse of a new era of device recall management. Rather than waiting for several deaths, the first case of death is divuldged. Importantly, doctors who deal with these devices are informed early. When this occurs, trust in the integrity of the device companies is improved as both doctors and their patients learn the magnitude of the inevitable challenges with these devices.

Call me an idealist, but I think we're making progress in management of these sophisticated devices and I think that there's lots of good that can be learned by Boston Scientific's latest decision to come clean early with their latest device problem. While there are still many issues that need improvement, like post-market surveillance of devices, things seem to be heading the right way.

Our next big challenge will be helping patients understand the realities concerning the reliability of these complex devices when deciding to implant them and communicating the efforts underway to assure their continued safety.

Thursday, April 26, 2012

ICU Nurse: "Did you see the video on the guy who hacked his pacemaker?"

Me: "Seriously?"

ICU Nurse: "Yeah, I think it was on Spike TV's show "1000 Ways to Die"

I show this rendition of the entertainment industry's version of "funny" with considerable reluctance, but I think it's important that doctors understand what today's younger generation is seeing these days on TV concerning pacemakers. While the skit starts off fairly comically, the writers of this script couldn't stop with a hacker playing with his own pacemaker, they had to include a video gamer "owning" the hacker, ultimately leading to "Way to Die #371."

Seriously, if you have a pacemaker, consider not viewing this. While there have been reports of at least one group reverse-engineering an implantable defibrillator's programmer, the idea of a video game controller "controlling" a pacemaker from another room stretches reality too far. Still, there are enough components of reality with this skit to create anxiety in patients with pacemakers. Furthermore, while I accept this was created for "entertainment," there are also enough inaccuracies to be concerned about what our younger generation might think about these devices when they get old enough to need them.

I'd be interested to see what my readers think about this show's episode: good, bad, funny, sad.

Perhaps the Heart Rhythm Society should consider sending VIACOM Media Networks (the owner of Spike TV) a letter on behalf of all of us who deal with these life-saving devices every day to make this episode "pay-per-view" rather than free to all as it exists now.

Andrew Foy, MD, a cardiology fellow at Penn State-Hershey University Medical Center pens an excellent overview of the causes of our current health care crisis in his perspective piece "Hospital of Cards." It simply is a must-read.

More than ever, the causes of our cost crisis in health care need to be understood if we are ever going to have a chance to right our Healthcare Hindenburg.

Monday, April 23, 2012

Health expenditures in the United States neared $2.6 trillion in 2010, over ten times the $256 billion spent in 1980. The rate of growth in recent years has slowed relative to the late 1990s and early 2000s, but is still expected to grow faster than national income over the foreseeable future.

So imagine my surprise when I saw this Medicare commercial last night that stated preventative health care services provided by Medicare were "free:"

CMS also uses the word "free" in the description of the new health care law's provisions on their Youtube channel:

"For those with Medicare, the health care law offers most preventive health care services for free."

Describing health care services as "free" dissociates people the cost reality of providing these services. It perpetuates the myth that we can have health care services without having to pay for them. Further, calling services "free" devalues the expertise and cost of facilities and regulatory oversight required to support such services.

Of course, public policy experts who promote these deceptive advertising techniques argue that these ads are justified because they encourage people to participate in preventative health services, thereby saving costs. But where are the data that these ads really work? Scientists know the realities of indeterminate, false positive and false negative testing of any screening test. We know the huge costs of additional testing that occurs in such in instance. Given our overriding health care cost concerns, should we not insist on proof of the cost-effectiveness of such a large-scale, national approach to preventive medicine services rather blithely assuming it works?

After all, the reality of health care today is that it is anything but "free."

Due to the event's overwhelming popularity at the ACC and the swank upcoming venue, please RSVP by 1 May to help Zoll with an approximate head count. For those who remain socially challenged, please come anyway. We understand. Rest assured you'll still be welcomed and there should be enough food, drink, er, educational content to convert even the most schizoid among us. After all, this is SOCIAL media we're talking about.

A live, interactive Twitter feed will accompany the talk for those who's like to follow along out there in the InterNets but can't attend in person - just use the hashtag #ZollHRS and a software program like Tweetchat to see the streaming commentary in near real-time. Feel free to post your questions and comments, too. The more entertaining educational, the better. (It'll be fun to see how many distinguished anonymous commenters we can identify!)

Also, I have learned that my fellow cardiac electrophysiology colleagues (who are forces in the social media in their own right) will be attending: John Mandrola, MD of Louisville, KY who blogs at the Dr. John M blog and for theheart.org's Trials and Fibrillations blog (Twitter: @drjohnm), and Edward J Schloss, MD of Cincinnati, OH (Twitter: @EJSMD). No doubt they'll be happy to share some of their insights with you as well.

Finally, if you're feeling particularly brave, consider leaving a comment to this post if you'll be attending so others can see who will be joining us. (Doing so just might inspire others who are on the fence about attending.)

Do these administrative and marketing types who love this term realize how phony this term sounds to most doctors? In fact, most doctors I know look at me as though I have three heads when I suggest they get involved in social media, much less "engage" with their colleagues or patients. I get the "there's no time," "too risky," or "not interested" rebuff from most.

But I also sense a growing tacit anxiety amongst the doctors unfamiliar with social media for the simple reason that these doctors don't like being late to innovative approaches in medicine. Deep down inside, they might even acknowledge that they should know more about this space, but really just don't want to spend the time to do so.

We should acknowledge, whether we like it or not, that the great majority of doctors are scared of using social media in health care. Sure, a Facebook page with family and friends is generally accepted. But a blog? Twitter? No frickin' way!

But I'd like to suggest something to the physician skeptics out there: don't "engage" in social media, "lurk" instead.

What do I mean by "lurk?" I mean, get an account, follow a group of people with common backgrounds and interests to yours, and don't say or type a thing. Just listen.

Here's why.

Most skeptical doctors have very real concerns about the permanence of what is written on the internet. They also are concerned about the many potential legal pitfalls that can befall doctors who use social media. After all, what might seem appropriate to one individual might be completely inappropriate to another. This might put a doctor on the defensive.

Fair enough.

But I believe doctors should still register with a social media service (Twitter, for instance) and reserve a name for themselves. Then they should try following a few people on the service. Then maybe follow a few more. Just look and listen to what is said there, but don't participate. Just "lurk." See what others say. If it agrees with you or is interesting, add those people to your follow list. Follow a journal. Follow a favorite newspaper, local news station or hobby website. Maybe even follow "the enemy" (whoever that might be). But just get used to the process. In time, I can almost guarantee that even the most skeptical of physician will see how these services can bring ideas and insights to them that they simply would never have had any other way. They'll be up on current affairs and might even learn something new before their friends or colleagues without having to utter a word online. And believe it or not, with practice they can even learn how to collaborate with others offline using direct (non-public) messaging.

Now more than ever, beyond all of these things, I believe there's something that social media provides to doctors that they don't appreciate at first. It is something that doctors are missing as medicine transforms from an independent solo or group practice setting to a series of giant corporate conglomerates:

Social media helps restore a sense of professional autonomy.

Doctors know they must keep current in the fast-changing world of medicine, particularly these days. Doctors need to appreciate their colleagues' struggles and concerns as the medical world evolves around us. Doctors need to know what patients are thinking, too.

But the beauty of social media for doctors is that it can help them with each of these needs without anybody knowing if a doctor so chooses. For doctors, I believe social media is a critical tool, but should not be considered an end-all. Just learning how to listen to the social media conversation not only provides an opportunity to participate in the medium IF (and only if) the doctor desires, but permits an instantaneous opportunity to raise one's voice to affect change when it's really needed.

Recently, another predictable Trojan-horse provision of the Patient Protection and Affordable Care Act appeared that promises to pit doctor versus patient by literally placing a price on patients' heads:

Twenty-thousand physicians in four Midwest states received a glimpse into their financial future last month. Landing in their e-mail inboxes were links to reports from Medicare showing the amount their patients cost on average as well as the quality of the care they provided. The reports also showed how Medicare spending on each doctor’s patients compared with their peers in Kansas, Iowa, Missouri and Nebraska.

The “resource use” reports, which Medicare plans to eventually provide to doctors nationwide, are one of the most visible phases of the government’s effort to figure out how to enact a complex, delicate and little-noticed provision of the 2010 health-care law: paying more to doctors who provide quality care at lower cost to Medicare, and reducing payments to physicians who run up Medicare’s costs without better results.

Of course, no real assessment of physician "quality" is taking place with this scheme nor any outcome assessment. "Quality" as it is defined in this scheme consists of only an electronic review of patient costs, doctor billing codes, and the patient characteristics of age, gender, Medicaid eligibility, and medical conditions. No government entity will actually observe and assess any physician in practice to determine their "value" to the system. Instead, patients electronically determined to be "low-cost" will be heralded as favored electronic "value" benchmarks. Even the health care law's original physician cheerleader, former Administrator of the Center for Medicare and Medicaid Services Donald Berwick, MD, was taken back:

“We do have to be cautious in this case. It could lead to levels of gaming and misunderstanding and incorrect signals to physicians that might not be best for everyone.”

Sunday, April 15, 2012

This morning’s New York Times examines the Association of American Medical Colleges’ (AAMC) answer to restoring the “heart and soul” of medicine by adding social sciences pre-requisites to the Medical College Admission Test (MCAT).

“Yes, we’ve fallen in love with technology, and patients are crying out, saying, ‘Sit down and listen to me,’ ” said Dr. Charles Hatem, a professor at HarvardMedicalSchool and an expert in medical education.

While I’m the first one to support a patient-centric approach to health care, why would the AAMC prepare their medical students for a health care world that will not exist?Are we not pretending and misleading our future physicians with such a pre-requisite for medical school admission?

The AAMC’s has a responsibility to prepare their students for the realities of today’s physician. Developing selection criteria for medical school based on social and humanitarian coursework without addressing the reality of today’s increasingly computer-screen-focused medical practice is whistling in the dark. As it is developing today, they would be more effective by preparing their students with typing lessons and pre-selecting them for unflagging conformity and rule-following skills.

In my experience, most medical students and fellows today have no idea of the looming threat that exists to practicing medicine in the way they imagine it.If the AAMC is truly concerned about patient-centric medicine, they would promote student activism to participate in policy changes that insist on more patient contact.But as it stands now, the idea that the inclusion of these social science pre-requisites to the MCAT is like dancing while Rome burns.

When articles are submitted for publication in a scientific journal, they undergo a process called peer review.In that process, highly respected scientists with experience in the subject matter of the submitted manuscript review the new work and decide if it is worthy for publication. During the process of peer review, the reviewers determine if the hypothesis of the work is supported by the available data and if the work is sufficiently valuable to the scientific community.Usually there are at least two reviewers who independently reach their conclusion regarding the manuscript and who report their decisions to the journal's editor. The editor ultimately determines the manuscript's fate.During this process, the authors are notified of the publication decision and feedback is provided to the authors by way of a written critique. That way, if a paper is rejected, authors can still benefit from the process in the hopes future submissions are improved.

This morning, St. Jude Medical undergoes a similar process, but in a more public way.Because the company chose to seek retraction of a scientific peer-reviewed manuscript by Dr. Robert G. Hauser from the Heart Rhythm Journal, an independent customer-reviwer, Edward J. Schloss, MD, Director of Cardiac Electrophysiology at The Christ Hospital in Cincinnati, OH, decided to subject St. Jude Medical's request to scientific review. (I'll call it a "customer review") Dr. Schloss hypothesized that differences in search methodology of the MAUDE database used by the company could explain the discrepancy in numbers of deaths found by Hauser et al’s Heart Rhythm Journal manuscript and the company's own numbers.His crystal clear analysis appears this morning at Cardiobrief and brings into sharp focus the severe shortcomings of St. Jude’s claims.

By way of background, readers of his work should know that Dr. Schloss attempted to offer this analysis at the Heart Rhythm Journal before publishing his analysis in its current format, but recieved a one-sentence reply from the Heart Rhythm Journal's editorial staff, stating the work would not be worthy of publication there. We can only speculate why his request was rejected.

So he published his analysis on Cardiobrief instead.

Dr. Schloss should receive our appreciation for his dogged determination to get to the truth. With his matter-of-fact and scientific analysis, he provides an invaluable service to his colleagues and our patients.Like all of us, he wanted to understand the truth behind the Riata/Riata ST defibrillator lead safety statistics.

But the value of this work extends further. Just like the scientific peer review process that rejects a manuscript on its first pass, we can only hope that St. Jude Medical learns a powerful lesson about their customers and the ever-watchful and increasingly influential medical blog-o-sphere.

Thursday, April 12, 2012

The St. Jude-MDT smackdown on the Riata lead performance continues. (For some background, here's my original post).

After seeking a retraction of Robert Hauser, MD's paper that identified 22 deaths from the Riata lead in the Heart Rhythm Journal, St. Jude's attempt to secure the retraction of the peer-reviewed paper that was released electronically is rebuffed by the journal's editor, Doug Zipes, MD:

“I have no knowledge of their data and therefore cannot accept a statement from them to contravene the results from the peer review process,” Zipes said.

Next, St. Jude offers their side of the causes of the deaths in a letter from their medical director. This letter was helpful but still leaves questions regarding the leads' long-term reliability.

And then St. Jude issues yet another press release that displays 377 deaths from Medtronic's Sprint Quatro lead on their website. The reader is left to wonder why. It's almost like a scene from Keeping Up With the Kardashains, where they just can't stop their incredulous foot stomping.

St. Jude acknowledged years ago there there were problems with this class of defibrillator leads. To those of us in practice, it is not suprising there are problems with these same leads now. If fact, we continue to find new clinical challenges when managing these leads. We are concerned about at least one case report (to be presented at HRS this year) of device defibrillation failure from multiple high voltage shocks supposedly delivered through a high voltage lead impedance of 0 ohms. Why St. Jude continues to suggest that their pulled Riata leads really aren't as bad as claimed seems incongruous with their professed need to recall them.

Electrophysiologists and patients need more credible information about the likelihood of failure of these leads and ways to follow patients to prevent further deaths. New softare upgrades to provide eaarly warning alerts, registries, or updated recommendations regarding the routine follow-up of these leads would be welcomed.

What we don't need are more media temper tantrums. This problem is hard enough without having to endure the spin.

The EKG hung outside the door with a new name attached.On a cursory glance, it looked pretty normal.He entered the room.There before him was a relatively young patient, medium build, nothing unusual.The computer schedule suggested it was just another case of atrial fibrillation.You’ve got an hour, he thought.Plenty of time.But he knew there was never just another case of atrial fibrillation.There are just too many plays in the playbook for this disorder.

But he was a seasoned veteran at the game.He had seen most things and had strategies for most of them.If X, then Y.If Y then Z.Not that hard, really.Most of the time.But this was not to be “most of the time.”

He reviewed the story, examined the patient, and reviewed the tracings.Delightful patient: productive, married, young kids, otherwise healthy, no risk factors for stroke.Amongst the screens and screens of collected data on this nice person, there it was: classic paroxysmal atrial fibrillation with relatively fast ventricular response, starting and stopping, starting and stopping, again and again on the Holter recording.

At first, it seemed like a chip shot: “I can fix this.”

Until he inquired further. “Seriously, you don’t feel this?”

Didn’t feel a thing.Felt fine, in fact.If it weren’t for the spouse, the patient wouldn’t be here.

He paused.

“But I can fix this!”

Then he thought: “But what if the cure is worse than the disease?What if there was a complication?What if he made things worse instead of better?Imagine a stroke in this person, this parent, this worker.How much better can you make someone who’s asymptomatic?”

“But I can fix this!”

There are a million things we can do to patients with atrial fibrillation: ablations, cardioversions, atrial occlusion devises, lariats, endocardial and epicardial mazes, all in the interest of curing the disorder.Our training, skills, equipment, reimbursement, marketing teams, egos, productivity clauses and culture of care constantly drives this process.In turn, we splash the happy patient who was cured from their disorder across our billboards, ever eager to do more.

But what most people will never see is the patient who is turned away; the one whom doing nothing invasive was the safest and best treatment for that individual even though the procedure, more likely than not, would have been successful.

Such a play is not sexy.It’s not innovative.It occassionally results in an adverse patient online rating. And for the system, it’s not lucrative.

Tuesday, April 10, 2012

It's like going to a grocery store for food but no price labels exist on any of the items. You collect these items and then go to the checkout counter. Your items are scanned but the clerk's screen shows no prices and the no one in the store has any idea what the items cost.

You then leave with the items, paying nothing at the time, only to receive a bill months later for an exorbitant amount that has been determined by someone who colluded with the store owners to set the price. Then these same miscreants decide a percentage that you must pay.

Friday, April 06, 2012

St. Jude Medical, a widely-used manufacturer of implantable cardiac devices, finds they have a bit of a problem with a form of insulation that surrounds wires contained in several lines of their pacing and defibrillator leads. They decide to pull these products from the market after substantial evidence that their leads' reliability falls below their standards.

A credible doctor, Robert G. Hauser, MD, known for his work in reviewing medical device safety issues, published a perspective piece critical of the post-market surveillance of the Riata leads in the New England Journal of Medicine. St. Jude Medical takes issue with Dr. Hauser, and publishes a rebuttal in the same issue of New England Journal of Medicine.

Dr. Hauser then submits a paper to the scientific peer-reviewed Heart Rhythm Journal for publication. The paper reveals deaths that might be caused by St. Jude Medical's faulty leads. The reviewers feel it is an important paper to share with their readership. The paper is published.

Today we find that St. Jude Medical is REALLY not happy with Dr. Hauser and demands that his paper be retracted from the Heart Rhythm Journal on the basis of their competitor's lead data reliability that they feel was misreported. The same letter fails to mention their own quality issues.

They then issue a press release to assure viral media spread in an attempt to discredit the physician's findings far and wide before facts can be verified. They say in their press release that they are justified in their action because Dr. Hauser failed to come to them before publishing his article:

St. Jude Medical was not consulted prior to the publication, nor asked to validate any of the data against its returns analyses. Since the manuscript was published, the company has spent more than 300 hours attempting to reach the same conclusions as Dr. Hauser, but can find no way of analyzing the MAUDE database that reproduces the same numbers reported in the manuscript. The company has identified duplicate reports, inconsistent categorizations and failures to include all available reports.

Ladies and gentlemen, this is an electronic SMACKDOWN!

Interestingly, word on the street is that a not-so-pleasant article about St. Jude's lead issue and the problems therein is about to be published in a major newspaper. (Addendum 4/6/2012 @ 11:07pm: Here's the New York Times article now in print)

Wednesday, April 04, 2012

Today, St. Jude Medical will be proactively informing physicians and patient of the withdrawal of their older-generation Quicksite and QuickFlex silicone left ventricular pacing leads (Models 1056T, 1058T, 1156T and 1158T)from the market after reports have surfaced of externalized conductors. According to their notification, there have been 39 confirmed cases out of 171,000 leads sold worldwide. While none of the pacing leads have demonstrated evidence of malfunction, the nature of this malfunction is important because it can occur without detection unless the patient undergoes fluoroscopic (x-ray) evaluation. The newer versions of the unipolar QuickFlex (Model 1056K) and Quickflex Micro (Model 1258T) and Quartet model 1458Q are NOT subject to this recall because their construction utilizes St. Jude's Optim insulation rather than silicone insulation.

(Click image to enlarge)

For St. Jude Medical, this latest revelation comes at a difficult time as physicians are still trying to deal with the management of St.Jude's earlier-generation recalled silicone defibrillator leads, the Riata and Riata ST. The revelation that this externalization can now affect St. Jude's bradycardia left ventricular pacing leads will no doubt affect physician's device selection. It is also clear that St. Jude Medical's portfolio of products for their lucrative cardiac rhythm management division will be significantly impacted.

For patients with these left ventricular pacing leads, follow-up of their system may involve x-ray evaluation on an intermittent basis, but I do not think that St. Jude and its physician advisory board will recommend removal of these leads, given the risks of infection and trauma that might be inherent to that procedure.

More likely, careful routine follow-up of these leads will be all that is required for now with the addition of at least one surveillance x-ray evaluation of the patient's LV lead and RV lead systems.

-Wes

4 Apr 2012 @ 10:55 am CST: Updated to include photo.

Disclaimer: Please understand that the opinions expressed in this blog are mine alone and do not represent the views of St. Jude Medical nor NorthShore University HealthSystem. I have no financial ties with St. Jude Medical but do serve on the speaking circuits for Medtronic, Boston Scientific, and Zoll Medical.

Monday, April 02, 2012

These days, it feels like my life is a tale of two ends of the emotional spectrum. There are days when I am so elated and full of exuberance that it would rival Mary Poppins. Other days are melancholy, which fills me with guilt. As much as I tell myself I have absolutely no right to feel anything but happy and grateful for the rest of my life, I occasionally feel sad and angry.

But I have come to realize that feeling bad at times is OK. After all, it's all a part of life.

I can't seem to quell my desire to make up for lost time. Thanks to the selfless act of an organ donor I will never meet, I now have the time to learn how to savor every second of the rest of my life.

Sunday, April 01, 2012

Until last week, the government's confidence on the constitutionality of the Patient Protection and Affordable Care Act (PPACA) seemed all but certain. Now, they're not so sure it might stand.

Of course, most American's are wondering: "Okay, if it gets repealed, then what?"

First, it is unlikely things will change right away. Many of the changes we've seen in health care with funding of the electronic medical record and forcing the collaboration between doctors and hospitals were created by the earlier economic "Stimulus" package funding, not the PPACA.

But for those of us involved in health care, a whole host of opportunities arise for our health care system if the PPACA falls. It is no secret that the biggest problem of our health care system is its rising cost relative to inflation. While the constitutionality of Obamacare may become its immediate undoing, the continued runaway costs that were not managed by the creation of such a gigantic new system would have eventually destroyed our health care system (and perhaps our economy) anyway. Already, new 10-year cost estimates far exceed original estimates.

If the PPACA is struck down, legislators will have an opportunity to address the problem of cost sustainability head-on to our health care system. The current health care ruling, if it plays out as anticipated, will need a viable, solvent alternative. The alternative will be a challenge to construct as special interests spend millions to lobby our legislators. But Congress should be increasingly aware that they are viewed by most Americans as divisive and largely ineffective; this could be a chance to change that perception for there is much both sides of the aisle can agree upon. They understand the need for affordable health care for the most needy. And most understand the cost conundrum must be addressed.

So what should Congress do?

In many ways, the answer might be easier than we all think:

Fix what's broken first.

Rather than creating a new, larger government health care system based on an 2700-page nearly unreadable health care law that creates at least 115 new agencies and winds between countless government agencies and disconnected bureaucracies, we should move to fix what's broken with Medicare and Medicaid first with an eye toward fixing what matters most to Americans.

If we've got waste, fraud, and abuse to the extent we are told, then fix it. We don't need new agencies to do so.

Admit there are limits to what can and will be paid for, set a budget, and stick to it.

If we care about our kids being uninsured, then fix it.

If care about people with pre-existing conditions not being insured, then fix it. But be honest with limits.

If people with sufficient means aren't contributing enough for their health care, fix it, but don't restrict what care those folks can obtain on their own nickel.

If doctors are saying they are overburdened with documentation requirements that don't improve patient outcomes or safety, then fix it. Stop perpetuating wasteful documentation mandates that add nothing to patient outcomes.

If we care about families going broke from health care expenses, then fix it. As a corollary:
if people don't know what things cost until it's too late to avoid bankruptcy, then fix it.

If costs are too high for medications, then fix it. Don't allow direct-to-consumer advertising and save a billion dollars (or more) for consumers. Open overseas markets to generic medication manufacturers that can prove the quality of their product. Things like this make patients the priority, not special interests.

If we don't have enough people caring for our population, then fix it. But move with caution - quality must be maintained: consider the costs of truncating supervised clinical training in favor of producing doctor mills.

If prices for materials and goods are held artificially high by government's fee payment schedule, then fix it. Legislators should ask themselves: do we really need pharmacy benefit managers and group purchase organizations that add no value for the patient? Can you say "i-n-t-e-r-n-e-t?"

Rather than trying to fixing exerything that ails our system all at once, take it piece by piece. Vet the issues openly rather than behind closed doors. Since prices are the priority, make prices for elective procedures and medical equipment available online to patients AND doctors. Patients must be the priority to our new initiatives, not special interests. Most of all, make the lower cost of health care and quality of health care the priorities and stop promising that the quantity of care we provide can remain unlimited to all.

But the one thing that Congress should absolutely NOT do is kick the health-care-cost can down the road any further. Otherwise, any new measure to preserve our health care system will be just as worthless to the sustainability of health care and our economy as the paper they're printed on.

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About Me

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005.
DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.